RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY.
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV. RETROVIR IV Infusion is a sterile solution for intravenous infusion only. Each mL contains 10 mg zidovudine in Water for Injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH to approximately 5.5. RETROVIR IV Infusion contains no preservatives.
RETROVIR IV Infusion in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Maternal-Fetal HIV Transmission:
RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).
Description of Clinical Studies:
Therapy with RETROVIR has been shown to prolong survival and decrease the incidence of opportunistic infections in subjects with advanced HIV disease at the initiation of therapy and to delay disease progression in asymptomatic HIV-infected subjects.
RETROVIR in combination with other antiretroviral agents has been shown to be superior to monotherapy in one or more of the following endpoints: delaying death, delaying development of AIDS, increasing CD4+ cell counts, and decreasing plasma HIV-1 RNA. The complete prescribing information for each drug should be consulted before combination therapy that includes RETROVIR is initiated.
Pregnant Women and Their Neonates:
The utility of RETROVIR for the prevention of maternal-fetal HIV transmission was demonstrated in a randomized, double-blind, placebo-controlled trial (ACTG 076) conducted in HIV-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells/mm3 (median in the treated group: 560 cells/mm3) who had little or no previous exposure to RETROVIR. Oral RETROVIR was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by intravenous administration of RETROVIR during labor and delivery. Following birth, neonates received oral RETROVIR Syrup for 6 weeks. The trial showed a statistically significant difference in the incidence of HIV infection in the neonates (based on viral culture from peripheral blood) between the group receiving RETROVIR and the group receiving placebo. Of 363 neonates evaluated in the trial, the estimated risk of HIV infection was 7.8% in the group receiving RETROVIR and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%. RETROVIR was well tolerated by mothers and infants. There was no difference in pregnancy-related adverse events between the treatment groups.
Media Articles Related to Retrovir (Zidovudine)
NYU researchers dramatically improve ART adherence for minority PHLA
Source: Compliance News From Medical News Today [2015.04.07]
Novel behavioral intervention improves treatment outcomes for HIV-infected individuals who have previously delayed, declined, or discontinued antiretroviral therapyUp to 60% of persons living...
Published Studies Related to Retrovir (Zidovudine)
A randomized trial of punctuated antiretroviral therapy in Ugandan HIV-seropositive adults with pulmonary tuberculosis and CD4 T-cell counts of >/= 350 cells/muL. [2011.09.15]
BACKGROUND: Optimal treatment of human immunodeficiency virus (HIV)-associated tuberculosis in patients with high CD4 T-cell counts is unknown. Suppression of viral replication during therapy for tuberculosis may block effects of immune activation on T cells and slow HIV disease progression... CONCLUSIONS: Short-term antiretroviral therapy during tuberculosis treatment in patients with CD4T-cell counts of >350 cells/muL was safe and associated with clinical benefits.
Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. [2011.08.01]
BACKGROUND: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009... CONCLUSIONS: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ~70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.
Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)--associated tuberculous meningitis. [2011.06]
BACKGROUND: The optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-associated tuberculous meningitis is unknown... CONCLUSIONS: Immediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis. Clinical Trials Registration. ISRCTN63659091.
Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. [2011.06]
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects... Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.
Challenges in PMTCT antiretroviral adherence in northern KwaZulu-Natal, South Africa. [2011.06]
BACKGROUND: Women living with HIV in sub-Saharan Africa face significant challenges in accessing HIV care and adhering to antiretroviral therapy. Most reports have focused on issues relating to long-term adherence such as those surrounding stigma and disclosure, hunger, cultural factors, lack of accurate health information, lack of social support, medication side effects and overcrowded health systems. Information related to the challenges facing pregnant women when taking antiretrovirals for prophylactic purposes is limited. The "Kesho Bora Study" is a multicentre prevention of mother-to-child transmission (PMTCT) trial in sub-Saharan Africa evaluating the PMTCT efficacy of triple therapy until cessation of breast feeding compared to short course zidovudine monotherapy in a predominantly breast feeding population. Following unexplained discrepancies during objective adherence assessments, a sub-study was conducted at one site to examine the underlying adherence issues... CONCLUSION: Antenatal women in northern rural KwaZulu-Natal face significant challenges in taking antiretroviral PMTCT prophylaxis.
Clinical Trials Related to Retrovir (Zidovudine)
Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma [Terminated]
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an
antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving
zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune
system and slow down or keep the cancer cell from growing.
PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon
alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic
virus type 1-associated adult T-cell leukemia/lymphoma.
Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-na�ve HIV-infected Patients [Recruiting]
The primary objective of the study is to compare the tolerance and safety between a low-dose
Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV
patients initiating a first line antiretroviral therapy. The investigators expect that the
low-dose regimen will show improved tolerability and safety compared to the standard dosage,
with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or
increasing their anaemia grade during the first 6 months of treatment.
The secondary objectives of the study is to compare the efficacy of the two dosing regimen,
as measured by classical clinical and biological markers: the number of new AIDS defining
illness, the mortality rate, the proportion of patients achieving virological success and
the mean CD4 cell count increase from baseline.
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection [Active, not recruiting]
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric
formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in
comparison to an innovator product. Establishing the bioequivalence of a newly developed
age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral
dispersible tablet or a reconstitutable suspension for children is invaluable for future
product registration and availability of the products to children, thus filling the void in
pediatric HIV/AIDS therapy.
A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients [Completed]
To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody
positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In
addition, the administration of AZT appears to have induced a remission of psoriasis in one
case study. In light of AZT's antiviral activity and potential effectiveness as an agent for
the treatment of psoriasis, this would be the most likely treatment for HIV positive,
psoriatic patients whose disease progresses quickly.
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure [Completed]
Reports of Suspected Retrovir (Zidovudine) Side Effects
Foetal Exposure During Pregnancy (76),
Premature Baby (23),
Maternal Exposure During Pregnancy (19),
Patent Ductus Arteriosus (11),
Foetal Growth Restriction (10),
Congenital Cytomegalovirus Infection (9),
Tricuspid Valve Incompetence (8), more >>
Page last updated: 2015-04-07